Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05581017

Collaborator

(none)

376

Enrollment

Location

27.8

Actual Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Pancreaticoduodenectomy Biliary Tract Infection Bacterial	Procedure: Preoperative biliary drainage

Study Design

Study Type:

Observational

Actual Enrollment :

376 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Association of Cephalosporin Resistance in Intraoperative Biliary Cultures With Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy - A Retrospective Cohort Study

Actual Study Start Date :

Jun 16, 2020

Actual Primary Completion Date :

Sep 10, 2022

Actual Study Completion Date :

Oct 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
No PBD Patients without preoperative biliary drainage before pancreaticoduodenectomy
PBD < 2 months Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage.	Procedure: Preoperative biliary drainage Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.
PBD ≥ 2 months Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage.	Procedure: Preoperative biliary drainage Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

Arm

Intervention/Treatment

No PBD

Patients without preoperative biliary drainage before pancreaticoduodenectomy

PBD < 2 months

Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage.

Procedure: Preoperative biliary drainage

Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

PBD ≥ 2 months

Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage.

Procedure: Preoperative biliary drainage

Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

Outcome Measures

Primary Outcome Measures

Rate of surgical site infections [30 days post operatively]
Prevalence of cephalosporin resistance in intraoperative biliary cultures [At the time of operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing pancreaticoduodenectomy between May 23rd 2016 to October 29th 2020

Exclusion Criteria:

Patients without intraoperative biliary culture
Patients with unknown date of preoperative biliary culture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki Central Hospital	Helsinki		Finland

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Principal Investigator: Timo O Tarvainen, MD, Gastroenterological Surgery, Helsinki University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timo Tarvainen, Principal Investigator, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT05581017

Other Study ID Numbers:

HUS-115-2020-56

First Posted:

Oct 14, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Surgical Wound Infection

Bacterial Infections

Cholangitis

Study Results

No Results Posted as of Oct 18, 2022